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Title:

Methods of treating cancer

Abstract:

The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo.

1. A method of treating lung cancer in a patient, comprising orally administering a single therapeutically effective dose of up to 400 mg of suberoylanilide hydroxamic acid
(SAHA) represented by the following structure: ##STR00062## or a pharmaceutically acceptable salt or hydrate thereof.

2. The method of claim 1, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 200 mg daily.

3. The method of claim 1, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 400 mg daily.

4. A method of treating Non-Hodgkins lymphoma in a patient, comprising orally administering 200 mg twice daily of suberoylanilide hydroxamic acid (SAHA) represented by the following structure: ##STR00063## or a pharmaceutically acceptable salt
or hydrate thereof.

5. A method of treating myeloma in a patient, comprising orally administering a single therapeutically effective dose of up to 400 mg of suberoylanilide hydroxamic acid (SAHA) represented by the following structure: ##STR00064## or a
pharmaceutically acceptable salt or hydrate thereof.

6. The method of claim 5, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 200 mg daily.

7. The method of claim 5, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 400 mg daily.

8. A method of treating breast carcinoma in a patient, comprising orally administering a single therapeutically effective dose of up to 400 mg of suberoylanilide hydroxamic acid (SAHA) represented by the following structure: ##STR00065## or a
pharmaceutically acceptable salt or hydrate thereof.

9. The method of claim 8, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 200 mg daily.

10. The method of claim 8, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 400 mg daily.

11. A method of treating ovarian carcinoma in a patient, comprising orally administering a single therapeutically effective dose of up to 400 mg of suberoylanilide hydroxamic acid (SAHA) represented by the following structure: ##STR00066## or a
pharmaceutically acceptable salt or hydrate thereof.

12. The method of claim 11, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 200 mg daily.

13. The method of claim 11, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 400 mg daily.

14. A method of treating cancer selected from the group consisting of colorectal carcinoma, Hodgkins lymphoma, bladder melanoma, renal carcinoma and prostate carcinoma in a patient, comprising orally administering a single therapeutically
effective dose of up to 400 mg of suberoylanilide hydroxamic acid (SAHA) represented by the following structure: ##STR00067## or a pharmaceutically acceptable salt or hydrate thereof.

15. The method of claim 14, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 200 mg daily.

16. The method of claim 14, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 400 mg daily.

33. A method of treating cancer in a patient, comprising orally administering a single therapeutically effective dose of up to 400 mg of suberoylanilide hydroxamic acid (SAHA) represented by the following structure: ##STR00068## or a
pharmaceutically acceptable salt or hydrate thereof.

34. The method of claim 33, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 200 mg daily.

35. The method of claim 33, wherein the SAHA or the pharmaceutically acceptable salt or hydrate thereof is orally administered as a single dose of 400 mg daily.

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